Fast Forward Pharmaceuticals starts phase II trials of FFP104 anti-CD40 monoclonal antibody

The move follows the completion of a phase I study in healthy volunteers. FFP104, which was licensed from PanGenetics, is indicated to treat several autoimmune diseases and inflammatory conditions.

The first patients has been enrolled in the PBC phase II trial, which is being carried out in the Netherlands, UK and Italy, with first results anticipated in the second half of this year.

Fast Forward Pharmaceuticals is partnering with the UK-PBC consortium, an MRC sponsored research network featuring 150 NHS Trusts across the country, to discover and develop new as well as enhanced treatment modalities for PBC.

The phase II study in patients with moderate to severely active Crohn’s disease will be undertaken in Belgium and the Netherlands.

It follows the successful results of a previous trial carried out by PanGenetics in which a chimeric version of FFP104 demonstrated promise in reducing clinical symptoms and improving histological activity scores in a dose dependent manner.

Fast Forward Pharmaceuticals CEO Mark de Boer said: "PBC is a disease with precious few treatment options, and new therapeutic modalities are desperately needed. And although current medications can help control Crohn’s disease, no cure exists.

"FFP104 is expected to interfere with the abnormal immune reaction underlying the disease, induce long-term remission, lower the risk for developing complications, and the requirement for surgery."

CD40 also plays an important role in the efficient activation of T-cells by antigen presenting cells (APCs). It may also be expressed on endothelial cells, epithelial cells, fibroblasts, airway smooth muscle cells, neuronal cells, and other non-lymphoid cells.